Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Exploring the Opinions of Irish Dairy Farmers Regarding Male Dairy Calves.

Background: There has been very little previous research in Ireland on the farmers' opinions regarding calf welfare issues. Calf welfare, particularly for male dairy calves, has assumed greater importance in Ireland in recent years due, in part, to an increase in the number of dairy cattle over the past decade. The objective of this study was to explore dairy farmers' views on a broad range of issues related to the expansion in the dairy herd. Methods: A survey was developed to capture the views of farmers regarding male dairy calves. The majority of questions were quantitative, and a final open-ended question collected qualitative data. The survey was distributed to ~2,900 dairy farmers via text message and 881 responses were received. Results: The sample was composed almost entirely of dairy farmers, although ~20% also had a beef enterprise on their farm. Fifty eight percent of the farmers were concerned with the increase in the number of male dairy calves in recent years. The EU's abolition of milk quotas, the profitability of dairy farming compared to other farm types, and guidance from farm advisors were the three highest ranked drivers behind the increase in the number of male dairy calves. The three highest ranked options for managing the number of male dairy calves were to increase exports, encourage greater use of sexed semen, and improve the beef merit of these calves. Eighty five percent of respondents stated that individual farmers had responsibility for making changes to the number of male dairy calves. The main themes arising from analysis of the responses to the open-ended question, seeking any additional comments, were breed, beef price, live exports, and sexed semen. Conclusions: Dairy farmers recognized the responsibility they have for making changes in respect of male dairy calves, and many demonstrated a willingness to make changes in this regard. The important role of other stakeholders, particularly suckler (system where reared from calf to beef) farmers, in rearing male dairy calves for beef production was also recognized. However, the issues of who bears the risks and costs associated with greater integration will have to be carefully considered.

Exploring the Opinions of Irish Beef Farmers Regarding Dairy Beef Integration.

Background: There has been very little previous research in Ireland on the opinions of farmers regarding dairy beef integration. The need for increased dairy beef integration has assumed a greater importance in Ireland in recent years due to a rapid expansion in dairy production, and associated increase in numbers of male dairy calves born on Irish farms. The objective of this study was to explore beef farmers' views on a broad range of issues related to dairy beef integration, using a survey methodology. The survey was distributed to approximately 4,250 beef farmers via email and 1,203 participated in the study. Results: The sample was composed almost entirely of beef farmers, although a very small proportion also had a dairy enterprise on their farm. Eighty percent of the farmers were concerned with the increase in the number of male dairy calves in recent years. Fifty seven percent of farmers responded that they were not willing to rear dairy bred calves for beef. Limousin, Aberdeen Angus and Hereford were the breeds farmers would be most willing to rear for beef. Good health, breed, and conformation were ranked as the main factors calf rearers consider when buying calves. Expectation of poor profit margin, expectation of poor-quality calves, and price volatility/market uncertainty were the top ranked factors dissuading farmers from rearing dairy calves for beef. The main themes arising from the qualitative question related to beef price/ability to make a profit, breed, and calf quality. Conclusions: While it is concerning that the majority of respondents expressed an unwillingness to rear dairy bred calves for beef, approximately a quarter of beef farmers indicated a willingness to rear beef-sired dairy calves for beef. In the qualitative responses, farmers described how their concerns about calf quality and their ability to make a profit from dairy bred calves would make it difficult for them to rear these calves for beef. Future strategy will have to consider how these challenges can be overcome and the issues of who bears the risks and costs associated with greater integration will have to be carefully considered.

Development and Application of a Prioritization Tool for Animal Health Surveillance Activities in Ireland.

Decisions around animal health management by stakeholders are often subject to resource limitation, therefore prioritization processes are required to evaluate whether effort is attributed appropriately. The objectives of this study were to develop and apply a surveillance prioritization process for animal health surveillance activities in Ireland. An exploratory sequential mixed research methods design was utilized. A prioritization tool was developed for surveillance activities and implemented over two phases. During the first phase, a survey was conducted which asked stakeholders to prioritize diseases/conditions by importance for Irish agriculture. In the second phase, experts identified the most important surveillance objectives, and allocated resources to the activities that they considered would best meet the surveillance objectives, for each disease/condition. This study developed a process and an accompanying user-friendly practical tool for animal disease surveillance prioritization which could be utilized by other competent authorities/governments. Antimicrobial resistance and bovine tuberculosis were ranked top of the endemic diseases/conditions in the Irish context, while African swine fever and foot and mouth disease were ranked top of the exotic diseases/conditions by the stakeholders. The study showed that for most of the diseases/conditions examined in the prioritization exercise, the respondents indicated a preference for a combination of active and passive surveillance activities. Future extensions of the tool could include prioritization on a per species basis.

Activation and dysregulation of the unfolded protein response in nonalcoholic fatty liver disease.

BACKGROUND & AIMS: Nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) are associated with known triggers of the unfolded protein response (UPR). The aims were to (1) evaluate the activity of UPR in NAFL and NASH and (2) correlate expression of UPR pathways with liver histology. METHODS: Messenger RNA (mRNA) and protein expression were measured by quantitative real-time PCR and Western blot, respectively. Apoptosis was assessed by TUNEL assay. Liver histology was scored using the NASH clinical research network criteria. RESULTS: Compared with subjects with the metabolic syndrome and normal liver histology (n = 17), both NAFL (n = 21) and NASH (n = 21) were associated with increased eukaryotic initiation factor-2alpha (eIF-2alpha) phosphorylation. Activating transcription factor 4 (ATF4) mRNA and protein, C/EBP homologous protein (CHOP), and growth arrest, DNA damage-34 (GADD34) mRNA were not increased in NAFL or NASH. Whereas immunoglobulin heavy chain binding protein mRNA was significantly increased in NASH, unspliced X-box protein-1 (XBP-1) protein did not increase. Also, endoplasmic reticulum degradation-enhancing alpha-mannosidase-like protein mRNA levels were inversely related to spliced XBP-1 mRNA in NASH. NASH was specifically associated with low sXBP-1 protein and increased JNK phosphorylation. This correlated with increased TUNEL activity in NASH. The histologic severity correlated with sXBP-1 mRNA and JNK phosphorylation. CONCLUSIONS: There is a variable degree of UPR activation in NAFL and NASH. Although both NAFL and NASH are associated with eIF-2alpha phosphorylation, there is a failure to activate downstream recovery pathways, ie, ATF4-CHOP-GADD34. NASH is specifically associated with (1) failure to generate sXBP-1 protein and (2) activation of JNK.

Nonalcoholic steatohepatitis is associated with altered hepatic MicroRNA expression.

UNLABELLED: The expression of microRNA in nonalcoholic steatohepatitis (NASH) and their role in the genesis of NASH are not known. The aims of this study were to: (1) identify differentially expressed microRNAs in human NASH, (2) tabulate their potential targets, and (3) define the effect of a specific differentially expressed microRNA, miR-122, on its targets and compare these effects with the pattern of expression of these targets in human NASH. The expression of 474 human microRNAs was compared in subjects with the metabolic syndrome and NASH versus controls with normal liver histology. Differentially expressed microRNAs were identified by the muParaflo microRNA microarray assay and validated using quantitative real-time polymerase chain reaction (PCR). The effects of a specific differentially expressed miRNA (miR-122) on its predicted targets were assessed by silencing and overexpressing miR-122 in vitro. A total of 23 microRNAs were underexpressed or overexpressed. The predicted targets of these microRNAs are known to affect cell proliferation, protein translation, apoptosis, inflammation, oxidative stress, and metabolism. The miR-122 level was significantly decreased in subjects with NASH (63% by real-time PCR, P < 0.00001). Silencing miR-122 led to an initial increase in mRNA levels of these targets (P < 0.05 for all) followed by a decrease by 48 hours. This was accompanied by an increase in protein levels of these targets (P < 0.05 for all). Overexpression of miR-122 led to a significant decrease in protein levels of these targets. CONCLUSIONS: NASH is associated with altered hepatic microRNA expression. Underexpression of miR-122 potentially contributes to altered lipid metabolism implicated in the pathogenesis of NASH.

Bariatric surgery in Medicare patients: greater risks but substantial benefits.

BACKGROUND: Recent reports have documented greater mortality for bariatric surgery in Medicare (MC) patients compared with patients from other payors. METHODS: We reviewed our database for the mortality and outcomes of 282 MC and 3169 non-Medicare (NMC) patients undergoing bariatric surgery. RESULTS: Of the MC patients, 27 were >65 years of age, and 255 were receiving disability. The average age was 48.45 +/- 11.8 years, and the average BMI was 52.4 +/- 10.0 kg/m2. NMC patients had average age of 40.0 +/- 10.1 years and a BMI of 50.6 +/- 9.1 kg/m2. The co-morbidities were greater in the MC patients than in the NMC patients (hypertension 71.9% versus 48.4%, diabetes mellitus 39.72% versus 19.4%, obstructive sleep apnea 46.45% versus 28.46%, and obesity hypoventilation syndrome 9.93% versus 2.71%). The mortality rate was 2.48% in the MC patients and .76% in the NMC patients. Mortality was absent in MC patients >65 years old. The percentage of excess weight lost was less in the MC patients (60.8%) than in the NMC patients (66.5%, P <.0001). The resolution of diabetes mellitus also differed (64.86% for the MC patients and 77.18% for the NMC patients; P = .0329). The male MC patients had more prevalent co-morbidities than did the male NMC patients (hypertension 79.17% versus 58.85%; diabetes mellitus 36.11% versus 24.83%; obstructive sleep apnea 79.17% versus 54.51%; and obesity hypoventilation syndrome 26.39% versus 7.64%). The operative mortality rate was 5.6% for the male MC patients and 1.5% for the female MC patients. The weight loss was similar for the male MC and male NMC patients. The male MC patients had slightly better resolution of both hypertension (MC patients 54.8% versus NMC patients 26.7%, P = .0025) and diabetes mellitus (MC patients 30% versus NMC patients 22.5%, P = .745). When the patients were stratified into low-, intermediate-, and high-risk groups using a previously validated risk scale, patients with similar risk factors had similar mortality in both groups. CONCLUSION: The results of our study have shown that disabled MC patients have greater operative mortality than NMC patients that appears to be associated with more prevalent risk factors. However, the risk was counterbalanced by a substantial improvement in health.

Does diabetes affect weight loss after gastric bypass?

BACKGROUND: Weight loss in diabetics improves glycemic control. We investigated whether diabetes mellitus (DM) adversely affects postgastric bypass weight loss. METHODS: Our database was queried for the demographics and outcomes of patients with and without DM who had undergone gastric bypass surgery. DM was subdivided by severity: diet-controlled, oral hypoglycemic agents, and insulin. RESULTS: Of the 3193 patients, 655 (20%) had DM. The DM group was older (45.8 +/- 10.4 yr versus 39.1 +/- 9.9 yr, P <.0001), with more co-morbidities: hypertension (70.5% versus 44.2%, P <.0001), sleep apnea (36.7% versus 26.1%, P <.0001), and venous stasis (5.6% versus 2.6%, P <.0001). More men had DM (25.6% versus 19.3%, P = .0006). The age-adjusted, preoperative weight, and body mass index were equal. A direct relationship was found between DM severity and age, weight, and co-morbidities. At 1 year, the DM group had a lower percentage of excess weight loss (60.8% +/- 16.6% versus 67.6% +/- 16.7%, P <.0001) and greater body mass index (34.2 +/- 7.1 kg/m(2) versus 32.3 +/- 7.2 kg/m(2), P <.0001). The percentage of excess weight loss was 67.6% for those without DM, 63.5% for those with diet-controlled DM, 60.5% for those with DM controlled by oral hypoglycemic agents, and 57.5% for those requiring insulin. DM resolved in 89.8% of those with diet-controlled DM, 82.7% of those taking oral hypoglycemic medication, and 53.3% of those requiring insulin. Hypertension resolution was greatest in patients without DM (74.4% versus 63.5%, P <.0001). CONCLUSION: The results of our study have shown that those with DM typically have more co-morbidities, despite having no difference in preoperative weight compared with those without DM. Despite the lower weight loss, those with DM had significant resolution of their DM and hypertension and should not be deterred from undergoing gastric bypass surgery.

Effect of location and speed of diagnosis on anastomotic leak outcomes in 3828 gastric bypass cases.

INTRODUCTION: Leaks after Roux-en-Y gastric bypass are a major cause of mortality. This study attempts to define the relationship between the leak site, time from surgery to detection, and outcome. METHODS: Retrospective review of 3,828 gastric bypass procedures. RESULTS: Of the leaks (3.9% overall), 60/2,337 (2.6%) occurred after open gastric bypass, 57/1,080 (5.2%) after laparoscopic gastric bypass, and 33/411 (8.0%) after revisions. Overall leak-related mortality after Roux-en-Y gastric bypass was 0.6% (22/3,828). Mortality rate from gastrojejunostomy leaks (38 in the open gastric bypass, and 43 in the laparoscopic) was higher in the open group than the laparoscopic group (18.4 vs 2.3%, p = 0.015). Median time of detection for a gastrojejunostomy leak in the open group was longer than in the laparoscopic group (3 vs 1 days, Wilcoxon score p < 0.001). Jejunojejunostomy (JJ) leak was associated with a 40% mortality rate. Initial upper gastrointestinal series did not detect 9/10 jejunojejunostomy leaks. Median detection time was longer in the jejunojejunostomy leak group than the gastrojejunostomy leak group (4 vs 2 days, p = 0.037). DISCUSSION: Leak mortality and time of detection was higher after open gastric bypass than laparoscopic gastric bypass. GBP patients with normal upper gastrointestinal (UGI) studies may harbor leaks, especially at the JJ or excluded stomach. Normal UGI findings should not delay therapy if clinical signs suggest a leak.

Selective, versus routine, upper gastrointestinal series leads to equal morbidity and reduced hospital stay in laparoscopic gastric bypass patients.

BACKGROUND: The use of routine upper gastrointestinal contrast radiology series (UGIS) after laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) can entail risk, expense, and patient discomfort. We have discontinued routine UGIS in favor of selective UGIS guided by patient symptoms and signs or elevations in the juxta-anastomotic drain amylase. We hypothesized that elimination of routine UGIS would not adversely affect morbidity or mortality. METHODS: We retrospectively reviewed the anastomotic leak, reoperation, and death rates and length of hospital stays for all patients who underwent LRYGB between two periods when either routine (November 2003 to December 2004) or selective (January 2005 to February 2006) postoperative UGIS were done. RESULTS: In group 1, were 267 patients who had undergone LRYGB with routine UGIS during November 2003 to December 2004. Group 2 consisted of 151 patients who had undergone LRYGB with selective UGIS during January 2005 to February 2006. The mean +/- standard error of the mean hospital stay for groups 1 and 2 was 4.3 +/- 0.3 and 3.3 +/- 0.2 days (P = .08), respectively. In group 1, 18 gastrojejunostomy leaks (6.7%) occurred compared with 6 (4.0%) in group 2 (P = .28). Also, 14 patients (5.2%) in group 1 required reoperation for anastomotic leak compared with 3 (2.0%) in group 2 (P = .13). Three patients (1.1%) in group 1 and no patients in group 2 died (P = .56). CONCLUSION: The elimination of routine UGIS did not adversely affect morbidity or mortality. The mean hospital stay in the group with selective UGIS decreased, although this decrease had not yet achieved statistical significance.

Participation in 150 min/wk of moderate or higher intensity physical activity yields greater weight loss after gastric bypass surgery.

BACKGROUND: The American College of Sports Medicine's position stand on weight loss and prevention of weight regain in adults has suggested that overweight adults should participate in a minimum of 150 min/wk of moderate intensity physical activity (PA). This study compared the 3-, 6-, and 12-month postoperative weight loss between gastric bypass surgery (GBS) patients who met or exceeded the recommended 150 min/wk of moderate or higher PA and those not meeting the recommendation. METHODS: The self-administered short version of the International Physical Activity Questionnaire was used to assess moderate or higher intensity PA participation at 3 (n = 178), 6 (n = 128), and 12 months (n = 209) after GBS. The patients' height and body weight were obtained to determine the kilograms of weight lost, percentage of excess weight loss, body mass index change, and total weight loss percentage. The weight loss differences were analyzed using analysis of covariance at each point, with age and preoperative body mass index as covariates. RESULTS: Patients reporting 150 min/wk of moderate or higher PA had significantly (P <.05) greater weight lost, percentage of excess weight loss, change in body mass index, and total weight loss percentage at 6 and 12 months postoperatively. The percentage of excess weight loss was 56.0% +/- 11.5% versus 50.5% +/- 11.6% and 67.4% +/- 14.3% versus 61.7% +/- 17.0% for the group meeting and not meeting the PA requirement at 6 and 12 months after GBS, respectively. No significant difference existed at 3 months after GBS. CONCLUSION: Participation in a minimum of 150 min/wk of moderate or higher intensity PA was associated with greater postoperative weight loss at 6 and 12 months postoperatively. Patients should be encouraged to meet or exceed this recommendation until prospective, randomized studies have definitively established a link between PA and greater postoperative weight loss and maintenance.

Pulmonary embolism complicating bariatric surgery: detailed analysis of a single institution's 24-year experience.

BACKGROUND: Morbidly obese patients undergoing bariatric procedures are at risk for pulmonary embolism (PE). Because large series are required to analyze low-incidence complications, factors predictive of PE have not been clearly defined. Since 1992, short-course heparin prophylaxis, beginning immediately before operation, has been used in this center. STUDY DESIGN: Prospective data on 3,861 patients undergoing bariatric procedures between 1980 and 2004 were queried. Factors analyzed included age, gender, body mass index, interval between procedure and PE, inpatient versus outpatient status, mortality, access method (open versus laparoscopic), and comorbidities. RESULTS: PE within 60 days of operation occurred in 33 patients (23 women, 10 men), for an incidence of 0.85%. No difference in incidence was noted between open (0.84%) and laparoscopic (0.88%) groups, nor did routine prophylaxis with heparin since 1992 decrease the incidence. The interval between procedure and PE was 13.2+/-2.6 (mean +/- SEM) days (open=13.0+/-3.0 days, laparoscopic 14.1+/-6.49 days, p=0.9). One-third of PEs occurred after hospital discharge. Pulmonary embolism-related mortality was 27%. A statistically greater body mass index was noted in PE patients compared with non-PE patients (57.2+/-2.4 kg.m(2) versus 49.9+/-0.2 kg/m(2), p < 0.01, Wilcoxon rank test). Multivariate logistic regression confirmed a primary role for preoperative weight as a predictor of PE; univariate analysis suggested an increased PE risk with obesity hypoventilation syndrome, anastomotic leak, and chronic venous insufficiency. CONCLUSIONS: Data demonstrated persistence of PE risk in the anticoagulation, laparoscopic-access era at a rate similar to that in the preanticoagulation, open-access era. Because one-third of PEs occur after hospital discharge, consideration should be given to continuing anticoagulants longer and to adopting a more aggressive policy of inferior vena cava filter prophylaxis, particularly in patients with high body mass index, obese hyperventilation syndrome, and venous insufficiency.

Laparoscopic transgastric removal of an eroded Angelchik prosthesis.

The Angelchik prosthesis is a silicone gel-filled implant historically placed around the gastroesophageal junction for the treatment of gastroesophageal reflux disease. Herein, we describe the laparoscopic transgastric removal of an Angelchik prosthesis that had eroded through the gastroesophageal junction of a patient 25 years after its placement. Under direct laparoscopic and endoscopic guidance, laparoscopic trocars were placed transabdominally, directly into the gastric lumen. Using 2-mm instrumentation, the prosthesis was transected, endoscopically snared, and removed perorally. The patient was discharged after a 3-day hospital stay. This is the first published description of a laparoscopic, transgastric approach to removal of a partially eroded prosthetic device to the stomach.

Physical activity stage of readiness predicts moderate-vigorous physical activity participation among morbidly obese gastric bypass surgery candidates.

BACKGROUND: Despite the ever-growing body of literature linking stage of physical activity readiness (PAR) with physical activity (PA) participation in overweight and obese populations, this relationship has not been examined among individuals seeking gastric bypass surgery (GBS). Furthermore, little is known about the specific intensity of activities undertaken by GBS candidates. Therefore, this study sought to determine whether greater PAR was associated with greater moderate-vigorous physical activity (MVPA) participation among GBS candidates. METHODS: The International Physical Activity Questionnaire (IPAQ), administered 2-weeks presurgery to 87 GBS candidates, determined MVPA participation using a formula based on metabolic equivalents (MET)-minutes/week. A stages-of-change measure categorized each candidate into one of five PAR stages: precontemplation, contemplation, preparation, action, or maintenance. RESULTS: The proportion of individuals in each PAR stage and the corresponding MVPA was as follows: contemplation (5.7%, 48.0 MET-minutes/week), preparation (46%, 394.0 MET-minutes/week), action (34.5%, 1614.0 MET-minutes/week), and maintenance (13.8%, 2056.7 MET-minutes/week). MVPA was significantly greater in candidates in the action or maintenance stages compared with those in contemplation (P =.008 and .025 for action and maintenance, respectively) or preparation (P < .0001 and .006 for action and maintenance, respectively). CONCLUSIONS: This study is the first to demonstrate a relationship between PAR and PA among GBS candidates, with 100% of the sample reporting either an intention to engage in PA or actual engagement in PA. This finding, coupled with the recent support for the importance of PA for weight loss/maintenance in GBS patients, warrants an investigation into the effectiveness of presurgical and postsurgical PA interventions matched to patients' PAR levels.

Effects of gastric bypass procedures on bone mineral density, calcium, parathyroid hormone, and vitamin D.

Weight loss after gastric bypass procedures has been well studied, but the long-term metabolic sequelae are not known. Data on bone mineral density (BMD), calcium, parathyroid hormone, and vitamin D were collected preoperatively and at yearly intervals after gastric bypass procedures. A total of 230 patients underwent preoperative BMD scans. Fifteen patients were osteopenic preoperatively, and three patients subsequently developed osteopenia postoperatively within the first year. No patient had or developed osteoporosis. At 1 year, total forearm BMD decreased by 0.55% (n = 91; P = .03) and radius BMD had increased overall by 1.85% (n = 23; P = .008); both total hip and lumbar spine BMD decreased by 9.27% (n = 22; P < .001) and 4.53% (n = 31; P < .001), respectively. By the second postoperative year, BMD in the total forearm had decreased an additional 3.62% (n = 14; P < .001), whereas radius BMD remained unchanged. Although total hip and lumbar spine BMD significantly decreased at 1 year, by year 2 both total hip and lumbar spine BMD only slightly decreased and were not significantly different from before the operation. Serum calcium decreased from 9.8 mg/dL to 9.2 during the first year (not significant [NS]) and then to 8.8 (NS) by the second year. Parathyroid hormone increased from 59.7 pg/mL (nl 10-65 pg/mL) preoperatively to 63.1 during year 1 (NS) and continued to increase to 64.7 by year 2 (NS). No difference was noted among levels of 25-hydroxy vitamin D preoperatively (25.2 ng/mL; nl 10-65 ng/mL), at 1 year (34.4), and at 2 years (35.4). Our data indicate that bone loss is highest in the first year after gastric bypass with stabilization, and that, in some cases, there is an increase in bone density after the first year.

Long-term data indicate a progressive loss in efficacy of adjustable silicone gastric banding for the surgical treatment of morbid obesity.

BACKGROUND: Many short-term follow-up reports on the efficacy of the adjustable silicone gastric band (ASGB) and its modification for laparoscopic insertion (Lap-Band) for the surgical treatment of morbid obesity have been reported in the surgical literature. However, long-term studies are lacking. METHODS: Between March 17, 1992, and January 7, 1997, 45 females and 17 males consecutively entered this prospective study. Forty ASGB and 22 Lap-Band were implanted. Mean age was 34 years (range 19-51); mean height was 171 cm (range 152-190); mean weight was 145 kg (range 100-214). Weight loss and adverse events associated with the device were observed over time. RESULTS: There was no operative mortality. Thirty intra-abdominal reoperations were necessary to correct complications related to the implanted ASGB and the Lap-Band. In the ASGB cohort, the body mass index (BMI) decreased from 50 to 36 over a 3-year period and then increased to 44 at 8 years after operation. In the Lap-Band cohort the BMI decreased from 47 to 40 at 1 year and then increased to 43 at 6 years after operation. Twenty-seven implantable devices (18 ASGB, 9 Lap-Band) have been removed to date. CONCLUSION: The results of this study do not support the use of ASGB devices for the surgical treatment of morbid obesity. The Lap-Band is less effective than ASGB.

Evaluation of pre- and postoperative physical activity participation in laparoscopic gastric banding patients.

BACKGROUND: Weight loss outcomes following laparoscopic adjustable gastric banding (LAGB) are widely variable, and physical activity (PA) participation improves these results. The purpose of this study was to retrospectively describe PA behaviors before and after LAGB and to evaluate the impact of PA on weight loss outcomes. METHODS: Participants were 172 individuals (145 females, mean age 43.3 ± 12.0 years, mean body mass index [BMI] 43.8 ± 5.1 kg/m(2)) who underwent LAGB at a university medical center. Height, weight, presence of comorbidities, and PA participation were assessed prior to and 3, 6, and 12 months after surgery. Those who reported engaging in ≥ 150 min of weekly moderate-to-vigorous PA (MVPA) were considered active. RESULTS: Less than 40 % of participants were active prior to surgery, while 31 % of those who were inactive before surgery became active at 6 months of follow-up. Unlike previous reports on gastric bypass patients, there was no statistically significant (p > 0.05) relationship between postoperative PA status and weight loss outcomes at 3, 6, or 12 months in LAGB patients. Interestingly, participants who reported ≥ 150 min of MVPA prior to surgery achieved approximately 10 % greater excess weight loss (p < 0.05) and a 2.4-kg/m(2) greater decrease in BMI (p < 0.05) at 1 year post-LAGB compared to those who were inactive preoperatively. CONCLUSIONS: In our sample, higher levels of preoperative PA participation were associated with improved weight loss outcomes following LAGB. We posit that higher preoperative volumes are indicative of habitual exercise and that those who report being active prior to surgery are likely to maintain these behaviors throughout follow-up.

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

BACKGROUND: Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. METHODS: Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. RESULTS: Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. CONCLUSIONS: VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

Long-term results of malabsorptive distal Roux-en-Y gastric bypass in superobese patients.

BACKGROUND: The purpose of the present study was to evaluate the safety, efficacy, and nutritional outcomes of malabsorptive distal Roux-en-Y gastric bypass (D-RYGB) 20-25 years later at a university hospital. METHODS: From 1985 to 1989, 49 mostly superobese (body mass index >50 kg/m(2)) patients had undergone D-RYGB. D-RYGB consisted of open laparotomy with a 50-mL proximal gastric pouch and gastroenterostomy performed 250 cm proximal to the ileocecal junction, with common channels of 50-150 cm. These 49 patients were compared with a similar group of 92 consecutive patients who had undergone long-limb RYGB, with a 75-cm biliopancreatic limb and 150-cm alimentary limb. RESULTS: The mean ± SD preoperative body mass index was 58.9 ± 9.3 kg/m(2). After 1 perioperative death secondary to pulmonary embolism, limb-lengthening revisions were required in 21 (43.7%) of the 48 remaining patients for protein-calorie malnutrition. Of the 23 with a 50-cm common channel, 13 required revision compared with 8 of 25 with ≥100-cm common channel (P <.05, chi-square). Of the 48 patients who had undergone D-RYGB, 8 had died 6-19 years after D-RYGB. Of the nonrevised patients, 19 (70.4%) of 27 had >5 years of follow-up. In these, the latest body mass index was 34.2 kg/m(2) at 10 ± 6.1 years. The percentage of excess weight loss was 66.8% ± 14%. The lowest late serum albumin level was 3.4 ± .5 g/dL (range 2.3-4.4). The mean 25-hydroxy vitamin D level was 14.6 ± 11.3 ng/mL. Compared with patients who had undergone long-limb RYGB, the D-RYGB patients had a significantly greater percentage of excess weight loss after 5 years but significantly lower albumin, hemoglobin, iron, and calcium levels. CONCLUSION: Although D-RYGB afforded superior long-term weight loss, it caused protein-calorie malnutrition requiring frequent revision. The nonrevised patients had frequent severe metabolic derangements. Thus, D-RYGB should not be the primary operation for morbid or superobese patients.